On May 30, 2017, the U.S. Food and Drug Administration’s (FDA’s) Food Safety Modernization Act (FSMA) rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals became final.

What is an FSVP?
It is a program that importers covered by the rule must have in place to verify that their foreign suppliers are producing food in a manner that provides the same level of public health protection as the preventive controls or produce safety regulations, as appropriate, and to ensure that the supplier’s food is not adulterated and is not misbranded with respect to allergen labeling.

What does the FSVP rule require?
The final rule requires that importers perform certain risk-based activities to verify that food imported into the U.S. has been produced in a manner that meets applicable U.S. safety standards.

Who is covered by FSMA’s FSVP rule?
For the purposes of FSVP, an importer is the U.S. owner or consignee of a food offered for import into the U.S. If there is no U.S. owner or consignee, the importer is the U.S. agency or representative of the foreign owner of consignee at the time of entry, as confirmed in a signed statement of consent. Exemptions must meet FDA criteria.  

What tasks are importers required to carry out under the FSVP rule?

  • Determining known or reasonably foreseeable hazards with each food
  • Evaluating the risk posed by a food, based on the hazard analysis, and the foreign supplier’s performance
  • Using that evaluation of the risk posed by an imported food and the supplier’s performance to approve suppliers and determine appropriate supplier verification activities
  • Conducting supplier verification activities
  • Conducting corrective actions

Importers who must comply with the FSVP rule must do so within 18 months after the final rule is published.

For more complete details on FSMA’s FSVP rule, visit FDA.gov.

More on the Foreign Supplier Verification Program rule:
FSMA, Food Safety Audits and Certifications
A New Era of Food Safety Regulation Begins
Ten Considerations for Developing a FSMA-Compliant Supplier Verification Program
 

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Author(s): Staff